Catalog Number

-

Brand Name

CUSTOM HEALTHCARE SYSTEMS INC

Version/Model Number

B9-18985

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OGD

Product Code Name

Custom Anesthesia Tray

Public Device Record Key

2484a41c-5685-42a5-bc03-ea44509e6442

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

August 13, 2018

Package DI Number

20811870030462

Quantity per Package

12

Contains DI Package

00811870030468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A